Cyclophosphamide and Etoposide and Methotrexate in Lymphoblastic Lymphoma - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Lymphoblastic Lymphoma

Intervention / Treatment

Drug: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide
Procedure: hematopoietic stem cell allograft

Detailed Description

Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts. Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the various clinical studies, have shown a best efficacy of ALL type treatments(in terms of overall survival and disease free survival). These treatments are based on an induction phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs after consolidation (delayed intensification). The prognostic factors of ALL are now better defined, determining risk groups. According to these prognostic indicators, the allograft could be proposed in first complete remission. Indicators are biological (hyperleukocytosis, chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central nervous system involvement), evolutive (salvage therapy needed to obtain complete remission), consideration of early response (cortico-sensibility and chemo-sensibility) and molecular responses (residual disease). On the other hand, the prognostic factors of LL are not well known. This study should permit to better define them. So the prognostic indicators of ALL, in this study, will be decisional for the indication of allograft. This treatment is based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).

Study Type

Interventional

Enrollment (Actual)

155

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Liege, Belgium, 4000
    - CHR de la Citadelle
  - Yvoir, Belgium, 5530
    - Cliniques Universitaires U C L de Mont Godinne
France
- - Angers, France, 49033
    - C H U D'Angers
  - Annecy, France, 74011
    - Centre Hospitalier de la région annécienne
  - Grenoble, France, 38043
    - CHU de Grenoble
  - Lens, France, 62300
    - Centre Hospitalier de Lens
  - Lyon, France, 69437
    - Edouard Herriot Hospital
  - Lyon, France, 69495
    - Pierre Benite Hospital
  - Marseilles, France, 13273
    - Institut Paoli Calmettes
  - Paris, France, 75000
    - Saint-Louis Hospital
  - Paris, France, 75013
    - La Pitié Salpêtrière Hospital
  - Paris, France, 75014
    - Cochin Hospital
  - Perpignan, France, 66046
    - Marechal Joffre Hospital
  - Poitiers, France, 86000
    - Centre Hospitalier de Poitiers
  - Reims, France, 51092
    - Chu de Reims Robert Debre Hospital
  - Rouen, France, 76038
    - Centre Henri Becquerel
  - Saint Priest En Jarez, France, 42271
    - Institut de Cancerologie de La Loire
  - Tours, France, 37044
    - Bretonneau Hospital
  - Vandoeuvre Les Nancy, France, 54511
    - CHU de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient with lymphoblastic lymphoma.
Aged from 18 to 59 years.
Medullary blasts rate less than 20%
Non previously treated
With or without central nervous system or meningeal involvement.
No contra-indication to anthracyclines.
No contra-indication to intensive treatments
Negative HIV serology test
Negative pregnancy test for all female patients of childbearing potential.
Able to be regularly followed up.

Exclusion Criteria:

Evolutive cancer with the exception of non melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
Prior treatment with chemotherapy.
Lymphoblastic Transformation of chronic myeloid leukaemia
Patient unable to be regularly followed-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event free survival Time Frame: 2 y	2 y

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities. Time Frame: 2 y	2 y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

Study Chair: Stephane Lepretre, MD, Centre Henri Becquerel, Rouen, France
Principal Investigator: Hervé Dombret, MD, Saint-Louis Hospital, Paris, France
Principal Investigator: Norbert Ifrah, MD, Centre Hospitalier Universitaire d'Angers, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Le Gouill S, Lepretre S, Briere J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4. doi: 10.1038/sj.leu.2403095.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

LL03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma

A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).